Puma’s Neratinib Brings Uncertain Efficacy, Tolerability Concerns To FDA Panel
Tyrosine kinase inhibitor has an effect in adjuvant breast cancer but ‘there remains some uncertainty regarding the true magnitude of the treatment effect,” FDA reviewers say; given incidence and severity of diarrhea, experts will be asked to consider whether there is a subpopulation with a more favorable risk/benefit profile.
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Puma's Nerlynx Scores Broad Label Across Adjuvant Breast Cancer Subgroups
US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.
Neratinib’s FDA Panel Nod Weighed Down By Indication Breadth Worries
Puma’s tyrosine kinase inhibitor gains recommendation from US advisory committee but faces concerns that proposed indication for extended adjuvant treatment in HER2-positve breast cancer is overly broad given unfavorable subgroup results in pivotal trial.
Emmaus Needs US FDA Advisory Cmte. To Rescue Sickle Cell Disease Candidate
FDA reviewers disagree with Emmaus' extrapolation methods for holes in efficacy data for its L-glutamine ahead of May 24 Oncologic Drugs Advisory Committee meeting.